Morphotek®, Inc. Announces Completion of Enrollment in the FAR-131 Trial for Relapsed Ovarian Cancer

Morphotek®, Inc. Announces Completion of Enrollment in the FAR-131 Trial for Relapsed... -- EXTON, Pa., March 27, 2012 /PRNewswire/ --

Clinical Study Seeks to Evaluate Farletuzumab in Combination with Standard of Care in First-Relapse Patients with Platinum-Sensitive Ovarian Cancer

EXTON, Pa., March 27, 2012 /PRNewswire/ -- Morphotek®, Inc., a subsidiary of Eisai Inc., announced today it has completed enrollment of the FAR-131 clinical trial. The study is a pivotal Phase 3 randomized trial of farletuzumab in first-relapsed patients with platinum-sensitive ovarian cancer. Farletuzumab is a humanized monoclonal antibody that targets folate receptor alpha (FRA), which is expressed on the majority of non-mucinous epithelial ovarian cancers as well as a subset of other carcinomas.
The trial is designed as a three-armed, randomized, double-blinded, controlled study in patients with platinum-sensitive ovarian cancer who relapse after first-line treatment with standard of care. FAR-131 tests the ability of farletuzumab at two different dosages in combination with second-line standard-of-care (carboplatin or cisplatin plus paclitaxel or docetaxel) for patients with platinum-sensitive disease to improve progression-free survival as compared to those treated with standard-of-care and placebo. Secondary endpoints include improvements in overall survival, objective tumor responses and the number of patients exhibiting longer second remission periods as compared to their primary remission.

FAR-131 was initiated in March 2009, and has reached its randomization target of 1080 patients at clinical sites in 30 countries located in North America, South America, Europe, Asia, Australia and the Middle East.

Farletuzumab is a monoclonal antibody that binds to and blocks the function of FRA, a cell surface protein on tumor cells that confers a growth advantage to tumorigenic ovarian cells in vitro. FRA has been demonstrated by several independent studies to be expressed on a variety of cancer types. The antibody also is being tested in a randomized Phase 2 study to assess its effect in patients with FRA⁺ non-small-cell lung adenocarcinoma in combination with standard of care in first-line therapy.

Further information on the clinical study can be found at www.clinicaltrials.gov, study number NCT00849667.

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NCT00849667

 

	Active, not recruiting	Efficacy and Safety of MORAb-003 in Subjects With Platinum-sensitive Ovarian Cancer in First Relapse Condition: Ovarian Cancer Interventions: Drug: MORAb-003 (farletuzumab);   Drug: 0.9% Saline